STERRAD HYDROGEN PEROXIDE CASSETTE, Model STERRAD 100S - Registration 80145900784 - Lots - See Annex 1 - Distribution List 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company informs that there is no impact on the health of the professional or the sterility of the processed devices. Still, it is very unlikely that this event will impact the use of the STERRAD® 100S sterilization system. ASP has already initiated corrective action to eliminate this defect in the manufactured product. • If the STERRAD® 100S sterilization system can not read the bar code, an error message may be displayed: "Can not accept cassette". • If the STERRAD® 100S sterilization system can read the bar code, the injection needles may align incorrectly or one of the following error messages may appear: "Injection Injection System (ISI)" or "Low Injection Pressure 1". In such situations, please read and follow the operating instructions for removing the STERRAD® 100S cassette. • If your STERRAD® 100S system experiences multiple cycle cancellations, it may be due to the damage of the injection needles, which may require a visit by the company's technical support.